Vasomedical has announced FDA 510(k) clearance of its BIOX 2302 combination ECG Holter/ambulatory blood pressure monitor and Model 1804 ambulatory blood pressure monitor. The BIOX 2302 expands on the 2301, which we covered last year, with a 12-lead ECG, while the Model 1804 provides stand-alone blood pressure monitoring. The BIOX 2301 and 2302 are the only FDA cleared devices which provide ECG Holter and BP monitoring in a singe unit.
More details from the press release:
With the new clearance by the U.S. FDA, Vasomedical now offers both 3-channel (Model 2301) and 12-channel (Model 2302) Combined Holter ECG/ABP Monitors. While they can also be configured by the user to record ECG or blood pressure data only, the newly cleared Model 1804 and the previously cleared Model 1305 provide economic alternatives for applications where only blood pressure or ECG recording is needed. All Vasomedical-BIOX™ series monitors work with the CB Series Analysis Software, also previously cleared by the U.S. FDA, for data scanning, analysis and reporting.